Z-0715-2022 Class II Terminated
FDA device recall Z-0715-2022 was initiated by Stryker Leibinger GmbH & Co. KG on December 29, 2021 and is designated Class II. Reason for recall: Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side. The recall status is terminated (terminated December 21, 2023). Affected quantity: 74.
Recall Details
- Product Type
- Devices
- Report Date
- March 9, 2022
- Initiation Date
- December 29, 2021
- Termination Date
- December 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74
Product Description
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Reason for Recall
Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.
Distribution Pattern
Worldwide distribution - US Nationwide.
Code Information
UDI: 07613252084334; Lot Number: 3R7YHD